Invasive Hemodynamic Response in Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-007048
Sponsor Protocol Number: 15-007048
About this study
The purpose of this study is to compare the hemodynamic effects of Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults (age ≥ 40 years)
- Severe, symptomatic valvular aortic stenosis identified by Doppler transthoracic echocardiogram defined as:
- AVA < 1.0 cm2, OR
- AVA index <0.6 cm2/m2, OR
- Peak AV jet velocity ≥ 4 m/s, OR
- Mean resting gradient > 40 mmHg
- Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for transfemoral TAVR.
- TAVR procedure must be performed in the cardiac catheterization laboratory for hemodynamic data recording
Exclusion Criteria:
- Patients who do not have adequate ileofemoral arteries for a transfemoral approach and require an alternative access (transapical, transaortic or transubclavian).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mackram Eleid, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available